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FLORIDA MEDICAL SALES INC.
FLORIDA MEDICAL SALES INC · Model FMSI-828 · UDI-DI 00857444006002
10
510(k) clearances
1,587
Adverse events (23 deaths)
20
Recalls
192
Facilities
Description
FMS HOLTER KIT - 1 PATIENT DIARY, 7 ELECTRODES, 1 RAZOR, 2 TAPE CARDS, 1 SCRUB PAD, 2 ALCOHOL PADS, 2 AA ALKALINE BATTERIES, 1 I.D. CARDS.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-03-15 | Graphic Controls Acquisition Corporation | Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard require |
| 2022-03-15 | Graphic Controls Acquisition Corporation | Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard require |
| 2022-03-15 | Graphic Controls Acquisition Corporation | Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard require |
| 2022-03-15 | Graphic Controls Acquisition Corporation | Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard require |
| 2022-03-15 | Graphic Controls Acquisition Corporation | Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard require |
| 2022-03-15 | Graphic Controls Acquisition Corporation | Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard require |
| 2021-10-06 | 3M Company - Health Care Business | Potential for breakage of the ECG electrode carbon stud from the eyelet. |
| 2020-09-15 | 3M Company - Health Care Business | Corrosion could cause performance failures in the product. |
| 2020-09-15 | 3M Company - Health Care Business | Corrosion could cause performance failures in the product. |
| 2020-09-15 | 3M Company - Health Care Business | Corrosion could cause performance failures in the product. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.